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Caliper Eyes Expansion into Companion Dx with New Platforms

By Edward Winnick

SAN FRANCISCO (GenomeWeb News) – Caliper Life Sciences hopes to receive the CE IVD Mark this year for its new LabChip Dx instrument as it looks to potential partnerships to help build content for the new platform, President and CEO Kevin Hrusovsky told GenomeWeb Daily News.

Speaking in advance of Caliper's presentation Thursday at the JP Morgan Healthcare Conference here, he also said his firm believes it has the tools pharma firms will want in developing companion diagnostics.

Caliper launched the LabChip Dx system earlier this week with a focus on building the firm's presence in the molecular diagnostics market. The system can analyze large numbers of multiplex samples using minimal sample volume and eliminates the need to further purify or dilute diagnostic PCR products, the firm said.

Its launch was quickly bolstered by the announcement of an alliance with Korean molecular diagnostics firm Seegene to place its SeePlex multiplex diagnostic assays on the LabChip Dx platform. Seegene has already placed its first order, Caliper said today, for 17 LabChip DX systems, valued at over $500,000.

As part of that deal, Seegene's network of distributors will market and distribute the Seeplex assays, which can run 10 tests simultaneously, outside of the US in a preferred partnership for use with the LabChip Dx. Hrusovsky told GWDN that he hopes Seegene will ultimately want to use Caliper for its US distribution of MDx assays as well.

In addition, he hopes Caliper will be able to make 510(k) submissions with the US Food and Drug Administration for assays under the Caliper name. Hrusovsky said the firm intends to partner for content in the "mid-plex" range.

The new LabChip DX, in combination with the firm's tissue-based imaging capabilities recently acquired through its CRI buy, are two key parts of the firm's strategy for building a companion diagnostics and integrated molecular diagnostics business. However, Hrusovsky noted that the initial focus of the tissue imaging business is not companion diagnostic partnerships but rather the diagnostics market.

Speaking at the conference, Hrusovsky said that the firm can now address $2 billion in end markets versus $1 billion before it bought the tissue imaging technology firm and launched the LabChip DX.

Another part of the firm's operations that plays into companion diagnostics is the Caliper Discovery Alliances and Services business, which has been conducting toxicity screening of compounds for the Environmental Protection Agency. This service also will be able to help with biomarker validation, Hrusovsky said.

While Caliper's technologies have obvious application in the cancer research and diagnostics space, Hrusovsky said that metabolic conditions, inflammation, and central nervous system disorders are other areas that could be targeted with the new platform.

He also noted that the firm would soon begin training its two sales forces, currently focused separately on in vitro and in vivo technologies, to cross-sell the firm's products in the pathology market. He said that while the sales teams have been separate, "there is some revenue synergy there, and there are pathologists on both sides."

Caliper may look to acquire technologies or companies that "continue the evolution of the path we're on," said Hrusovsky, noting that reagents for its molecular diagnostics and tissue-imaging platforms could be key targets.

While the firm divested some smaller, non-core parts of its business in 2009 and 2010, Hrusovsky said Caliper is "pretty much done with the shedding."

Caliper expects to report 2010 revenues of around $123.5 million, above its guidance, and believes it can reach revenues of as much as $140 million in 2011, Hrusovsky said. The firm hopes to increase its revenues at a clip of around 20 percent annually and is aiming for revenues of $240 million in 2014, of which $200 million is expected to be organic.

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